ODAC
The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
FDA Expert Panel to Consider Limiting Gastric, Esophageal Cancer Immunotherapies to PD-L1 Expressors
The ODAC will weigh risk-benefit analyses from the FDA and sponsors on Keytruda, Opdivo, and Tevimbra when given with chemo in all-comers and in PD-L1-positive subgroups.
FDA Advisors Unanimously Support Using MRD to Expedite Multiple Myeloma Drugs Through Trials
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ODAC members agreed that minimal residual disease can be a reliable biomarker for accelerated approval, but sponsors must provide confirmatory evidence of clinical benefit.
An advisory committee on Friday will consider whether minimal residual disease can reliably predict if multiple myeloma drugs are benefiting patients.
FDA Approves Bristol Myers Squibb, 2seventy Bio's Abecma in Earlier-Line Multiple Myeloma
Regulators acted in concert with the advisory committee that last month voted in favor of the CAR T-cell therapy's benefit.